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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Adult Rigid Intracardiac Sucker; bulk, nonsterile

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  Class 2 Device Recall Sarns Adult Rigid Intracardiac Sucker; bulk, nonsterile see related information
Date Initiated by Firm September 13, 2011
Date Posted October 17, 2011
Recall Status1 Terminated 3 on December 10, 2012
Recall Number Z-0054-2012
Recall Event ID 59912
Product Classification Sucker, cardiotomy return, cardiopulmonary bypass - Product Code DTS
Product SARNS INTRACARDIAC SUCKER, BULK, NON-STERILE
Code Information Catalog number 11009010
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
Manufacturer Reason
for Recall		 Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 9/13/2011 Terumo sent a letter entitled "URGENT MEDICAL DEVICE REMOVAL" to its customers that included the name and description of the device, lot numbers, the potential hazard, correction, the reason for the recall and instructions. Customers are to review the notice, ensure that all users are aware of the issue, and a recall response form to be completed and returned. Customers are to call Terumo CVS Customer Service to obtain a Return Goods Authorization number. The letter also included MedWatch reporting information and stated that Customers with questions should call 1-800-521-2818.
Quantity in Commerce 5700
Distribution Worldwide Distribution -- USA, Belgium, Australia, Mexico, and Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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